Sanofi and Regeneron Pharmaceuticals recently announced positive results from two Praluent-focused Phase 3b/4 Odyssey-DM trials involving diabetes patients.
"Patients with long-standing diabetes, including insulin-treated patients, are at high risk of cardiovascular disease," Dr. Lawrence Leiter, chair of the Odyssey-DM Steering Committee and director of the Lipid Clinic at the Li Ka Shing Knowledge Institute at St. Michael's Hospital at University of Toronto, said in a statement. "The positive results from Odyssey-DM Insulin provide valuable information on the efficacy and safety of Praluent in this high cardiovascular risk group."
In one study, Praluent met its primary endpoint by reducing low-density lipoprotein cholesterol (LDL-C). In the other, the drug met its primary endpoint by showing superiority to usual care in reducing non-high-density lipoprotein cholesterol (non-HDL-C).
"Mixed dyslipidemia is common in people with type 2 diabetes and further increases CV risk, and yet it is difficult to treat with available therapies," Dr. Robert Henry, member of the Odyssey-DM Steering Committee and director of the Center for Metabolic Research at the VA San Diego Healthcare System. "The results of Odyssey DM-DYSLIPIDEMIA showed that in a real-world setting, Praluent, on top of maximally tolerated doses of statins, significantly reduced non-HDL-C, another measure of bad cholesterol, and was superior to usual care. Praluent may be another option for physicians who need to further help their diabetes patients with clinical ASCVD manage their lipid profiles."